HIGH

Elixir by Coco March Sunscreen Recalled Over CGMP Violations

Elixir by Coco March recalled tinted mineral sunscreen due to CGMP deviations. The recall affects products distributed in California, Colorado, Florida, Puerto Rico, and Washington. Consumers should stop using the product immediately and seek guidance from healthcare providers.

Quick Facts at a Glance

Recall Date
October 10, 2025
Hazard Level
HIGH
Brands
SUNSCREEN, CA-Botana International
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
5 states
At-Risk Groups
GENERAL

Hazard Information

CGMP Deviations

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact CA BOTANA International, Inc. or your healthcare provider for guidance. Notification method: Letter

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Product Details

The recalled product is Elixir by Coco March Tinted Mineral Sunscreen SPF 50, containing Zinc Oxide 21%. It was distributed by VitaTienda Co U.S.A. and sold in 2.1 oz (62g) bottles. The affected lot is D53681, with an expiration date of March 31, 2027.

The Hazard

The recall stems from CGMP deviations, which indicate a failure to adhere to current good manufacturing practices. This can compromise product safety and quality.

Reported Incidents

There are no specific incidents or injuries reported related to this recall. However, the high hazard level suggests potential risks associated with using the product.

What to Do

Consumers should immediately stop using the recalled sunscreen. They should contact CA BOTANA International, Inc. or their healthcare provider for further guidance and information.

Contact Information

For more information, consumers can visit the FDA's website or contact CA BOTANA International, Inc. directly.

Key Facts

  • Recall date: October 10, 2025
  • Report date: December 3, 2025
  • Affected lot: D53681
  • Expiration date: March 31, 2027

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot D53681
exp 03/31/2027
UPC Codes
35192-050
35192-050-17
Affected States
CA, CO, FL, PR, WA
Report Date
December 3, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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